A Randomized Controlled Study of Digitalized Cognitive-behavioral Intervention for Childhood Anxiety
Study Details
Study Description
Brief Summary
The aim of the study is to evaluate the effectiveness of a digitalized cognitive-behavioral treatment for anxiety among school aged children. The participants are screened from the general population, as a part of the routine school health care check-ups. Half of the children with anxiety will receive the digitalized treatment program, while the other half will receive education about anxiety in internet.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Digitalized cognitive-behavioral intervention
|
Behavioral: Digitalized cognitive-behavioral intervention for anxiety
An internet-based CBT, including telephone coaching
|
| Active Comparator: Psychoeducation about anxiety
|
Behavioral: Psychoeducation about anxiety
Psychoeducative material about anxiety in internet
|
Outcome Measures
Primary Outcome Measures
- Change from Baseline to 6 months follow up; the Screen for Child Anxiety Related Disorders - child and parent reports [Change from baseline to 6 months follow up; symptoms during the last three months]
Comprises of 41 items assessing symptoms of general anxiety, separation anxiety, panic disorder, social anxiety, and school phobia; scoring 0-82 (higher score meaning more symptoms)
Secondary Outcome Measures
- Change from Baseline to 6 months follow up; the Child Anxiety Impact Scale - child and parent reports [Change from baseline to 6 months follow up; impact of anxiety during the last month]
Comprises of 27 items assessing the impact of anxiety on the daily life of the children at home, school and with friends; scoring 0-81 (higher score meaning higher impact of anxiety)
- Change from Baseline to 6 months follow up (in the Intervention group); the Development and Well-Being Assessment - child and parent reports [Change from baseline to 6 months follow up; varying time windows for different diagnoses]
A diagnostic interview to assess anxiety disorders among 2-17-year-old children
- Change from Baseline to 6 months follow up; the Revised Children Quality of Life - Questionnaire - child and parent reports [Change from baseline to 6 months follow up; QoL during the last week]
Comprises of 24 items assessing the health-related quality of life divided into six subscales: physical, psychological, self-esteem, family, social life, and school; scoring 24-96 (higher score meaning higher QoL)
- Change from Baseline to 6 months follow up; the Child Depression inventory - child report [Change from baseline to 6 months follow up; symptoms during the last two weeks]
Comprises of 28 items assessing the child's depressive symptoms; scoring 0-54 (higher score meaning more symptoms)
- Change from Baseline to 6 months follow up; the Strengths and Difficulties Questionnaire, extended version - parent report [Change from baseline to 6 months follow up; symptoms during the last six months]
Comprises of 25 items assessing the child's psychiatric symptoms and positive attributes, and an impact supplement; scoring 0-40 (prosocial scale is not included in the total score) (higher score meaning more problems)
- Change from Baseline to 6 months follow up of the relations with peers and school (not a standardized scale) [Change from baseline to 6 months follow up]
Experience of being bullied (traditional and cyberbullying), and feelings about school and teachers
- Change from Baseline to 6 months follow up; the Brief resilience scale - parent report (parental resilience) [Change from baseline to 6 months follow up; experience of the current resilience]
Comprises of six items assessing resilience; scoring 6-36 (higher score meaning higher resilience)
- Change from Baseline to 6 months follow up; the Depression Anxiety and Stress Scale Short Form - parent report (parental depression, anxiety and stress) [Change from baseline to 6 months follow up; symptoms during the last week]
Comprises of 21 items assessing parental depression, anxiety and stress; scoring 0-63 (higher score meaning more symptoms)
- Change from Baseline to 6 months follow up; the Customised Client Receipt Inventory Questionnaire - parent report [Change from baseline to 6 months follow up; service use during the last six months]
Assesses the child's use of school support services, and social and health care services
Eligibility Criteria
Criteria
Inclusion Criteria:
- Scoring ≥22 on SCARED
Exclusion Criteria:
-
no access to internet
-
insufficient language (Finnish until summer 2019, Finnish and Swedish from autumn 2019 onwards, when also Swedish version of the intervention was available) skills
-
visual or hearing impairment that hinders the use of the program
-
the child's mental retardation, autism spectrum disorder, suicidal intentions or severe mental disorder
-
the child's psychotherapy (ongoing or starting within 6 months)
-
the child's medication (for anxiety) started / changed within 2 months
-
current involvement with child protection services (i.e., removal of child custody, investigation of child abuse or neglect)
-
parent's severe psychiatric / somatic disease or other reason that hinders the parent to actively participate in the program
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Child Psychiatric Research Center, University of Turku | Turku | Finland | 20500 |
Sponsors and Collaborators
- University of Turku
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ANXIETY-2017